“A comparative study between effectiveness of external electrical muscle stimulation versus TENS in the Management
of Diabetic Peripheral Neuropathy”
A Dissertation Submitted In Partial Fulfillment
of the Requirements for the Degree of
MMAASSTTEERR OOFF PPHHYYSSIIOOTTHHEERRAAPPYY
With Specialization In
AADDVVAANNCCEEDD PPHHYYSSIIOOTTHHEERRAAPPYY IINN NNEEUURROOLLOOGGYY
Register Number: 27091410
Submitted to
THE TAMILNADU DR. M.G.R MEDICAL UNIVERSITY Chennai
JKK MUNIRAJAH MEDICAL RESEARCH FOUNDATION
COLLEGE OF PHYSIOTHERAPY
Department Of Post Graduate Studies
Komarapalayam - 638 183
April - 2011
“A comparative study between effectiveness of external electrical muscle stimulation versus TENS in the Management of
Diabetic Peripheral Neuropathy” Internal Examiner: External examiner:
A Dissertation Submitted In Partial Fulfillment
of the Requirements for the Degree of
MMAASSTTEERR OOFF PPHHYYSSIIOOTTHHEERRAAPPYY
To
THE TAMILNADU DR.M.G.R MEDICAL UNIVERSITY
Chennai
April – 2011
CCEERRTTIIFFIICCAATTEE
This is to certify that the research work entitled “A Comparative Study
Between Effectiveness Of External Electrical Muscle Stimulation Versus
TENS In The Management Of Diabetic Peripheral Neuropathy” was
carried out at JKK MUNIRAJAH MEDICAL RESEARCH FOUNDATION
COLLEGE OF PHYSIOTHERAPY, KOMARAPALAYAM, affiliated to
The Tamilnadu Dr. M.G.R Medical University, Chennai-32, towards partial
fulfillment for the award of Degree of “Master of Physiotherapy” course
with “Advanced Physiotherapy In Neurology” as specialization. This work
was done under my supervision and guidance.
Mr. D. KANNAN, M.P.T., (NEURO), M.I.A.P,
PRINCIPAL,
JKKMMRF COLLEGE OF PHYSIOTHERAPY,
KOMARAPALAYAM – 638 183.
CCEERRTTIIFFIICCAATTEE
This is to certify that the research work entitled “A Comparative Study
Between Effectiveness Of External Electrical Muscle Stimulation Versus
TENS In The Management Of Diabetic Peripheral Neuropathy” was carried
out at JKK MUNIRAJAH MEDICAL RESEARCH FOUNDATION
COLLEGE OF PHYSIOTHERAPY, KOMARAPALAYAM, affiliated to
The Tamilnadu Dr. M.G.R Medical University, Chennai-32, towards partial
fulfillment for the award of Degree of “Master of Physiotherapy” course
with “Advanced Physiotherapy in Neurology” as specialization. This work
was done under my supervision and guidance.
Mr. D. KANNAN, M.P.T., (NEURO), M.I.A.P,
PRINCIPAL,
JKKMMRF COLLEGE OF PHYSIOTHERAPY,
KOMARAPALAYAM – 638 183
AACCKKNNOOWWLLEEDDGGEEMMEENNTT
I would render my wholehearted gratitude to my “Family Member’s
And Friend’s”, who had given me the opportunity, guidance,
encouragement, and support throughout the course of my study.
I express my grateful thanks to Dr. J.K.K. Munirajahh, M.Tech.,
(Bolton), Managing Director, JKKMMRF College of Physiotherapy for
providing all necessary infrastructure for an excellent P.G. Programme.
I express deep concern and gratitude to Mr. D. Kannan, M.P.T.,
(Neuro) MIAP, Principal, JKKMMRF College of Physiotherapy for his
valuable suggestion, guidance and support.
The investigator acknowledges with all gratitude and deep
indebtedness for the guidance and encouragement provided by
Mr. D. KANNAN, M.P.T.(Neuro), MIAP, Principal, JKKMMRF College of
Physiotherapy.
The investigator expresses much gratitude to
Mr. A.AYYAPPAN, M.P.T. (Neuro), Mr. R. FERDINAND, M.P.T. (Ortho),
Mr. R. JOHN VINOTH RAJ, M.P.T. (Neuro). Mr. A.SARAVANAN, M.P.T.
(Cardio), Mrs. R. VISNUPRIYA, M.P.T. (Neuro) and Mrs. V.KOKILA,
M.P.T. (Ortho) for their valuable guidance.
The investigator also has much gratitude to Mr. K. DHANAPAL,
M.Sc., JKKMMRF College of Physiotherapy, statistician for his unrelenting
devotion and determination for statistical excellence.
The investigator is also indebted to her friends for their support and
criticism during the work of this dissertation.
The investigator extends her sincere thanks to subjects who took part
in the study.
Acknowledgement
TTAABBLLEE OOFF CCOONNTTEENNTTSS
INTRODUCTION
Aim of the study
Objectives
Hypothesis
REVIEW OF LITERATURE
MATERIALS AND METHODOLOGY
Materials
Study design
Study setting
Sampling method
Sample size
Study duration
Inclusion criteria
Exclusion criteria
Parameter
Procedure
Statistical tool
Page No.
01
03
03
04
05
12
12
12
12
13
13
13
13
14
14
14
15
DATA PRESENTATION
DATA ANALYSIS AND INTERPRETATION
DISCUSSION
SUMMARY AND CONCLUSION
RECOMMENDATIONS
BIBLIOGRAPHY
REFERENCE
APPENDIX
Definition of Terms
Parameters
Treatment techniques
Informed consent
Assessment Chart
17
18
30
37
39
40
41
43
43
45
48
50
51
LLIISSTT OOFF TTAABBLLEESS
Table I: Data presentation
Table II: pre vs post for NTSS-6 for group A
Table III: pre vs post for NTSS-6 for group B
Table IV: Mean difference between group A and B for
NTSS-6
Table V: pre vs post for LEFS for group A.
Table VI: pre vs post for LEFS for group B.
Table VII: Mean difference between group A and B for
LEFS.
Page No.
17
18
20
22
24
26
28
LLIISSTT OOFF GGRRAAPPHHSS
Graph I: Pre Vs Post for NTSS-6 for group A
Graph II: Pre Vs Post for NTSS-6 for group B
Graph III: Mean difference between group A and B for NTSS-6
Graph IV: pre vs post for LEFS for group A
Graph V: Pre Vs Post for LEFS for group B
Graph VI: Mean difference between group A and B for LEFS.
Page No.
19
21
23
25
27
29
LIST OF FIGURES
Figure I : Treatment given with stimulator
Figure II : Treatment given with TENS
Page No.
49
49
1
IINNTTRROODDUUCCTTIIOONN
Diabetes is severe disease affecting over hundred millions of people
endure from diabetes with in the world. In USA about 16 million people are
affected from diabetes.
It affects all age group from children to elderly individual by type II
Diabetes have greater damage of nerve ,kidney, eye and coronary heart
diseases.
Diabetes believed to be the national IV leading for death. In the
nervous system could also be disturbed or damaged causing severe pain, loss
of felling this situation is referred to neuropathy
Diabetic neuropathy is a complication caused by diabetes symptoms
includes numbness and some time pain in the hand, feet or in legs
Peripheral neuropathy is a problem with the nerve that carry
information to and from the brain and spinal cord this produce pain loss of
sensation and in ability to control muscle.
Peripheral means away from the center of the body distance from
spinal cord, ‘neuro” means nerve, ‘pathy’ means abnormal about 60 to 70%
of diabetic patient have mild to severe form of nervous system damage
which leads to diabetic poly neuropathy.
2
Peripheral nerves, called sensory nerves,sents messages (stimuli) to
the brain and spinal cord, so we can feel certain sensations. For example,
when we prick our finger, sensory nerves transmit this information to the
brain and we will feel a sharp sensation. Someone with sensory nerve
damage may feel numbness rather than pain.
Prevalence - the projected 18 millions of people increases in the
number of cases of diabetes in 2050, 37% are due to changes in
demographic composition, 27% are due to population growth, and 36% are
due to increasing rates.
Diabetic neuropathy is classified as peripheral, autonomic proximal
(or) focal, peripheral neuropathy is the most common type of diabetic
neuropathy and also called as distal symmetric neuropathy or sensorimotor
neuropathy. Peripheral neuropathy affects nerves of toes, feet, legs, hands &
arms. Feet & legs are likely to be affected before hands and arms.
The first treatment is to bring sensation back by bringing the blood
sugar level with in the normal range to prevent further nerve damage.
Diabetic peripheral neuropathy is treated with medication and physiotherapy
treatment modality like TENS, external electrical muscle stimulation and
exercises.
This study was carried out to determine the effectiveness of External
Electrical Muscle Stimulator and Transcutaneous electrical nerve stimulation
(TENS)in Management of Diabetic Peripheral Neuropathy using Neuropathy
Total Symptom Score-6 (NTSS-6) and LEFS.
3
AAIIMMSS AANNDD OOBBJJEECCTTIIVVEESS
AIM OF THE STUDY
To compare the effectiveness of External Electrical Muscle
Stimulator and Transcutaneous electrical nerve stimulation in Management
of Diabetic Peripheral Neuropathy.
OBJECTIVES OF THE STUDY
To determine the effectiveness of External Electrical Muscle
Stimulator in Diabetic Peripheral Neuropathy.
To determine the effectiveness of transcutaneous electrical nerve
stimulation in Diabetic Peripheral Neuropathy.
To compare the effects of External Electrical Muscle Stimulator and
Transcutaneous electrical nerve stimulation in Management of
Diabetic Peripheral Neuropathy in sensory reeducation.
To compare the effects of External Electrical Muscle Stimulator and
Transcutaneous electrical nerve stimulation in Management of
Diabetic Peripheral Neuropathy using lower extremity functional
scale.
To find out the effective treatment regarding pain, functional status,
and sensation in Diabetic Peripheral Neuropathy.
4
HHYYPPOOTTHHEESSIISS
NULL HYPOTHESIS
The null hypothesis states that there was no significant difference
between External Electrical Muscle Stimulation Versus Transcutaneous
electrical nerve stimulation in the Management of Diabetic Peripheral
Neuropathy.
ALTERNATE HYPOTHESIS
The alternate hypothesis states that there was significant difference
between External Electrical Muscle Stimulation Versus Transcutaneous
electrical nerve stimulation in the Management of Diabetic Peripheral
Neuropathy.
5
RREEVVIIEEWW OOFF LLIITTEERRAATTUURREE
L.Reichstein et. al.,(Apr 2005)
The aim of the study was to find out the effectiveness of high
frequency external muscle stimulation versus TENS on symptomatic
diabetic neuropathy .41 patient who is suffering from diabetes in which 20
patients with out pain and 21 patients with pain duration of treatment 30 min
daily for 3 consecutive days for both lower extremities .The parameter used
are HbA1c (mmol/l) and Neurological impairment scale. The result of the
study say that high frequency external muscle stimulation can ameliorate the
discomfort pain, reduction in HbA1c,improvement in Neurological
impairment scale associated with diabetic peripheral neuropathy than
TENS.
The conclusion of the study shows that external muscle stimulation is
more effective than TENS for diabetic sensory polyneuropathy.
Per M.Humpert MD et al (Jan 2009)
The aim of the study to find out the effect of external muscle
stimulation in improving burning sensation and sleeping disturbance in
patient with type 2 diabetes with symptomatic neuropathy. About 92 patients
with type 2 diabetes with neuropathy symptomatic are taken for study.
Patient treated with EMS twice a week for 4 weeks. The parameter used
numerical scale.
6
The result of the study shows that about 73% of patients is marked
improvement in numerical scale of symptoms such as pain, burning
sensation, numbness, sleeping disturbance and paresthesia.
The Study concluded that external muscle stimulation is an effective
treatment for symptomatic neuropathy patient with type 2 diabetes.
Peter EJ et al (oct.1998)
The purpose of the study was to evaluate electrical stimulation on
vascular perfusion in diabetic patients. About 19 patients were selected
based on transcutaneous oximeter. The parameter used is Transcutaneous
oximeter values of which vascular perfusion was measured before and after
external muscle stimulation for a period of two days.
The study result shows that external muscle stimulation induces
transient rise in skin perfusion in patient with diabetes.
The study concluded that external muscle stimulation is an effective
treatment for symptomatic neuropathy patient with type 2 diabetes.
MD Edward et al (oct. 2005)
The study was conducted to find out the development and validity
testing of the neuropathy total symptom score-6 (NTSS-6) questionnaires for
7
the study of sensory symptoms of diabetic poly neuropathy. About 205
patients where used in 10 centers in USA.
The study concluded that neuropathy total symptom score-6 was valid
assessment of neuropathy sensory symptoms of patients with diabetes and
diabetic polyneuropathy. It is more reliable and valid to evaluate diabetic
polyneuropathy in this well defined world.
Moharic et al (Sep. 2010)
Aim of the study was conducted to determine the effectiveness of
TENS in painful neuropathy condition. About 46 patients was treated with
tens for 3 consecutive hours for 3 weeks. Treatment effect was evaluated by
cold, warm ,cold pain threshold ,heat pain threshold, vibration perception
threshold and touch perception threshold.
The result concluded that there is no statistically significant changes in
cold, warm ,cold pain threshold ,heat pain threshold, vibration perception
threshold and touch perception threshold. It does not alter C fibers, A (delta),
nor A (beta) fibers mediated perception threshold.
Study concluded that TENS does not alter above fibers mediated
perception threshold in diabetic peripheral neuropathy.
8
Rose b et. al.,(2006)
The aim of the study was to evaluate the beneficial effect of external
muscle stimulation on glycaemic control in patient with type 2 diabetes .In
this study 16 patients on antihyperglycemic drug 6weeks of High frequency
external muscle stimulation. The parameter’s used are HbA1c, blood
samples where drawn.
The result of study shows that there is a reduction of blood sugar
level, body weight and HbA1c (-0.4%) in the patient with type2 diabetes.
The study concludes that EMS is an additional treatment option for
patients with type two diabetes who can not perform physical activity.
E Hultman and LL Spriet (may. 1985)
The study was conducted to evaluate the skeletal muscle metabolism,
contraction force and glycogen utilization during prolonged electrical
stimulation in human quadriceps muscles of 7 volunteer’s duration of 45 min
of electrical stimulation titanic trains at 20Hz lasting 1.6s separated by 1.6s
pause. Muscle biopsies where taken at rest and during stimulation that
reduces blood glucose level in diabetic patients. The parameter used is
muscle biopsies during rest and during stimulation.
The study result conclude that external stimulation increases the
skeletal muscle metabolism
9
M Lankisch et al
The aim of the study was to determine the new possibilities of
treatment for type 2 diabetes by means of external muscle stimulation. It’s a
12 week in these 2 weeks of external muscle stimulation. The electrode is
placed over the thigh and shunk .The GLUT 1 and GLUT 4, body weight
and HbA1c used as parameters .
The study result states that there is body mass index and HbA1c is
reduced and increase in GLUT 1 and GLUT 4.
The study concluded that external muscle stimulation is clinically
relevant to patients with type 2 diabetes could be demonstrated.
Deephika Sharma et al (Oct 2010)
The study was to evaluate the effect of external muscle stimulation on
blood sugar level and lipid profile of sedentary type 2 diabetes patients.
About 20 patients under gone electrical stimulation over quadriceps muscles
40 min/day/3 days/ week for continuous 2 weeks . Parameter blood test was
taken on 1st and last day of treatment.
The study result concludes that blood sugar level is reduced by means
of external muscle stimulation in type 2 diabetic patients.
The study concluded that external muscle stimulation is clinically
relevant to patients with type 2 diabetes could be demonstrated
10
Jill M Binkley et al (Jan. 1999)
The purpose of this study was to assess the reliability, construct
validity, and sensitivity to change of the Lower Extremity Functional Scale.
About 107 patients with lower-extremity dysfunction .
The study result states that Lower Extremity Functional Scale was
excellent.
Conclusion and Discussion . The Lower Extremity Functional Scale
is reliable, and construct validity was supported by comparison with the SF-
36. The sensitivity to change of the Lower Extremity Functional Scale was
superior to that of the SF-36 in this population. The Lower Extremity
Functional Scale is efficient to administer and score and is applicable for
research purposes and clinical decision making for individual patients.
MD Edward J Bastyr III 12(July 2005)
The aim of this study was to develop and validate a neuropathy
sensory symptom scale, the Neuropathy Total Symptom Score-6 (NTSS-6),
which evaluates individual neuropathy sensory symptoms in patients with
diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN) in clinical
trials.
The parameter’s used are numbness and/or insensitivity; prickling
and/or tingling sensation; burning sensation; aching pain and/or tightness;
sharp, shooting, lancinating pain; and allodynia and/or hyperalgesia.
11
The study result conclude that the Neuropathy Total Symptom Score-
6 (NTSS-6)provided a valid assessment of neuropathy sensory symptoms in
this sample of patients with diabetes mellitus and diabetic peripheral
neuropathy, which suggests that it may be useful for symptom evaluation in
clinical trials and practice. The Neuropathy Total Symptom Score-6 (NTSS-
6) showed internal consistency, test-retest reliability, and construct validity.
12
MMAATTEERRIIAALLSS AANNDD MMEETTHHDDOOLLOOGGYY
MATERIALS
Couch.
Pillows.
External Electrical Muscle Stimulator.
Transcutaneous Electrical Muscle Stimulator(TENS)
Electrode gel.
Strap.
Cotton.
Lower extremity functional scale and Neuropathy Total Symptom
Score-6 chart.
METHODOLOGY
Study Design
Quasi Experimental Study Design.
Study Setting
The study was conducted at out patient department in J.K.K.
Munirajahh Medical Research Foundation College of Physiotherapy,
Komarapalayam under the supervision of the higher concerns.
13
Sampling Method
Convenient sampling method.
Sample Size
Thirty patients with diabetic peripheral neuropathy, who comes under
the inclusion criteria, were taken for the study.
Study Duration
The study was conducted for a course of 6 months, and treatment
duration for each patient was 20 min per sitting, 4 sittings per week for one
month.
Inclusion Criteria
Age group –50 years and above.
Sex – both sexes.
Diabetic peripheral neuropathy.
HbA1(C) <8.
Neuropathy Disability Score (NDS) <6
14
Exclusion Criteria
Pregnancy.
Malignancy.
vessel involvement.
Patient with cardiac pacemaker.
Infective skin lesion
Varicose vein.
Presence of ulcer.
Insulin dependent diabetes mellitus.
HbA1(C)>8.
Amputation
Parameters
Neuropathy Total Symptom Score-6 (NTSS-6)
Lower Extremity Functional Scale.
Procedure
A total number of 30 patients having Diabetic peripheral neuropathy
who met the inclusion criteria were recruited by convenient sampling
method. After the informed consent obtained, they were partitioned into two
groups as Group A and Group B, with 15 patients in each.
15
Hence prior to the onset of treatment, pre-tests were conducted using
Neuropathy Total Symptom Score-6 and Lower Extremity Functional Scale
and results were recorded for both groups.
Statistical Tools
Paired‘t’ test:
The paired‘t’ test was used to find out the statistical significance
between pre and post test of patients treated with external electrical muscle
stimulation and TENS.
Formula: Paired‘t’ test:
s = 1
)( 22
−
−∑ ∑
nnd
d
t = s
nd
d = difference between pre test Vs post test values
d = mean difference
n = total number of subjects
s = standard deviation.
16
Unpaired‘t’ test:
The unpaired‘t’ test was used to compare the statistically significant
difference between Group A and Group B.
Formula: Unpaired‘t’ test:
s = 2
)1()1(
21
222
211
−+−+−
nnsnsn
t = 2
11
1
21
// nns
xx
+
−
n1 = total number of subjects in group A
n2 = total number of subjects in group B
1x = difference between pre test Vs post test of group A
1x = mean difference between pre test Vs post test of
Group A
2x = difference between pretest Vs post test of group B
2x = mean difference between pre test Vs post test of
Group B
s = standard deviation.
17
DDAATTAA PPRREESSEENNTTAATTIIOONN
TABLE I
S.No
Group A Transcutaneous electrical nerve
stimulation
Group B External Electrical Muscle
Stimulator
Neuropathy Total Symptom Score-6
(NTSS-6)
Lower Extremity Functional
Scale (LEFS)
Neuropathy Total Symptom
Score-6 (NTSS-6)
Lower Extremity Functional
Scale(LEFS) Pre Post Pre Post Pre Post Pre Post
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
12
11
12
10
11
9
10
11
11
12
11
10
10
11
12
7
6
5
6
6
5
6
6
6
8
7
6
5
6
7
35
36
38
37
40
41
42
43
37
36
40
41
35
36
44
55
51
52
55
59
57
60
58
50
49
61
60
51
50
60
10
11
12
12
10
11
9
9
11
10
12
11
11
9
8
2
3
2
3
2
3
2
2
2
2
3
3
3
2
2
39
37
38
35
41
40
42
44
45
43
35
36
37
39
38
75
71
70
69
68
74
72
69
73
70
74
75
68
69
71
18
DDAATTAA AANNAALLYYSSIISS AANNDD IINNTTEERRPPRREETTAATTIIOONN..
This section deals with the analysis and interpretation of data
collected from group A and Group B who underwent Transcutaneous
electrical nerve stimulation and External electrical muscle stimulator
TABLE – II
Group – A
Table II represents the mean values, mean difference, standard
deviation, and paired ‘t’ value between pre test Vs post test values of Patient
Rated diabetic peripheral neuropathy for group A who have been subjected
to Transcutaneous electrical nerve stimulation.
NTSS-6 Mean Mean
difference
Standard
deviation
Paired ‘t’
value
Pre test
Post test
10.86
6.1
4.76 0.79 23.02
It shows the analysis of Patient Rated Diabetic Peripheral Neuropathy;
the paired ‘t’ value of pre Vs post sessions of group A was 23.02 at 0.05
level of significance, which was greater than the tabulated value of 2.15.
This showed that there was a statistical significant difference in between pre
Vs post test results. The pre test mean was 10.86, the post test mean was 6.1
and mean difference was 4.76, which showed that there was a decrease in
Patient Rated Diabetic Peripheral Neuropathy in post test indicating the
recovery of selected samples in response to intervention.
19
Graph I – Patient-Rated diabetic polyneuropathy Evaluation of Group
A
10.866.1
0
20
40
60
80
100
NT
SS-6
PRE POST
Pre & Post test values
20
TABLE - III
Group – B
Table III represents the mean values, mean difference, standard
deviation, and paired‘t’ value of Patient Rated Diabetic Peripheral
Neuropathy for group B, who have been subjected to External Electrical
Stimulation.
NTSS-6 Mean Mean
difference
Standard
deviation
Paired ‘t’
value
Pre test
Post test
10.40
2.40
8
1
30.98
Table III shows the analysis of Patient Rated Diabetic Peripheral
Neuropathy; the paired ‘t’ value of pre Vs post sessions of group B was
30.98 at 0.05 level of significance, which was greater than the tabulated
value of 2.15. This showed that there was a statistical significant difference
in between pre Vs post test results. The pre test mean was 10.40, the post
test mean was 2.40 and mean difference was 8 , which showed that there
was a decrease in Patient Rated Diabetic Peripheral Neuropathy in post test
indicating the recovery of selected samples in response to intervention
21
Graph II – Patient-Rated diabetic polyneuropathy Evaluation of Group
B
10.42.4
0
20
40
60
80
100
NT
SS-6
PRE POST
Pre & Post test values
22
TABLE – IV
Table IV represents the comparative mean values, mean difference,
standard deviation, and unpaired‘t’ value between group A and group B on
Patient Rated Diabetic Peripheral Neuropathy.
NTSS-6 Mean Mean
difference
Standard
deviation
Unpaired ‘t’
value
Group A
Group B
4.76
8
3.24
0.895
9.92
Table IV shows the analysis of group A and group B with Patient
Rated Diabetic Peripheral Neuropathy. The unpaired‘t’ value of 9.92 was
greater than the tabulated ‘t’ value of 2.05 at 0.05 level of significance which
showed that there was statistically significant difference between group A
and group B. The mean value of group A was 4.76 and the mean value of
group B was 8, which showed that there was a greater improvement in group
B than group A.
Therefore, the study is rejecting the null hypothesis and accepting the
alternate hypothesis.
23
Graph III - Mean difference of Group A and Group B NTSS-6
4.76 8
0
20
40
60
80
100
NT
SS-6
GROUP A GROUP B
24
TABLE - V
Group – A
Table V represents the mean values, mean difference, standard
deviation, and paired ‘t’ value between pre test Vs post test values of
Diabetic Peripheral Neuropathy for group A who have been subjected to
Transcutaneous electrical nerve stimulation.
LEFS Mean Mean
difference
Standard
deviation
Paired ‘t’
value
Pre test
Post test
38.73
55.30
16.57
2.472
26
Table V shows the analysis of lower extremity functional scale.; the
paired ‘t’ value of pre Vs post sessions of group A was 26 at 0.05 level of
significance, which was greater than the tabulated value of 2.15. This
showed that there was a statistical significant difference in between pre
Vs post test results. The pre test mean was 38.73 , the post test mean was
55.30 and mean difference was 16.57 , which showed that there was an
increase in lower extremity functional scale in post test indicating the
recovery of selected samples in response to intervention.
25
Graph IV– LEFS of Group A
38.7355.3
0
20
40
60
80
100
LE
FS
PRE POST
Pre & Post test values
26
TABLE - VI
Group – B
Table VI represents the mean values, mean difference, standard
deviation, and paired ‘t’ value of lower extremity functional scale.
For group B, who have been subjected to External electrical muscle
stimulator.
.
LEFS Mean Mean
difference
Standard
deviation
Paired ‘t’
value
Pre test
Post test
39.27
71.20
31.93
4.245
28.99
Table VI shows the analysis of lower extremity functional scale, the
paired ‘t’ value of pre Vs post sessions of group B was 28.99 at 0.05 level
of significance, which was greater than the tabulated value of 2.15. This
showed that there was a statistical significant difference in between pre Vs
post test results. The pre test mean was 39.27-, the post test mean was 71.20
and mean difference was 31.93, which showed that there was an increase in
lower extremity functional scale in post test indicating the recovery of
selected samples in response to intervention.
27
Graph V– LEFS of Group B
39.27
71.2
0
20
40
60
80
100
LE
FS
PRE POST
Pre & Post test values
28
TABLE - VII
Table VII represents the comparative mean values, mean difference,
standard deviation, and unpaired ‘t’ value between group A and group B on
lower extremity functional scale.
LEFS Mean Mean
difference
Standard
deviation
Unpaired ‘t’
value
Group A
Group B
16.57
31.93
15.36
3.358
12.538
Table VII shows the analysis of group A and group B with lower
extremity functional scale .The unpaired ‘t’ value of 12.538 was greater
than the tabulated ‘t’ value of 2.05 at 0.05 level of significance which
showed that there was statistically significant difference between group A
and group B. The mean value of group A was 16.57 and the mean value of
group B was 31.93, which showed that there was a greater improvement in
group B than group A.
Therefore, the study is rejecting the null hypothesis and accepting
the alternate hypothesis.
29
Graph VI - Mean difference of Group A and Group B – LEFS
16.5731.93
0
20
40
60
80
100
LE
FS
GROUP A GROUP B
30
DDIISSCCUUSSSSIIOONN
The aim of the study was to compare the effectiveness of external
electrical muscle stimulation versus Transcutaneous Electrical Muscle
Stimulator in management of diabetic peripheral neuropathy.
L.Reichestein et.al used external electrical muscle stimulation for
treatment of patient’s diabetic peripheral neuropathy.41 patients were
selected and treated. The result showed that external electrical muscle
stimulation was found to be effective in treatment of diabetic peripheral
neuropathy.
Rose B et.al used Neuropathy Total Symptom Score-6 (NTSS-6),
Neuropathy Disability Score (NDS). and external electrical muscle
stimulation to assess the diabetic peripheral neuropathy. 16 patient with
diabetic peripheral neuropathy were selected and treated with external
electrical muscle stimulation. Based on the result the above study was
conducted.
Per M.Humpert MD et.al also used Neuropathy Total Symptom
Score-6 (NTSS-6) and Neuropathy Disability Score (NDS) are used as
parameters.
Based on the results of above studies, it is concluded that
Neuropathy Total Symptom Score-6 (NTSS-6), Lower Extremity
Functional Scale and Neuropathy Disability Score (NDS) could be used
to quantify the pain and functional status in diabetic peripheral
neuropathy.
31
In the analysis and interpretation of Neuropathy Total Symptom Score-6 (NTSS-6) in group A: The paired‘t’ value of 23.02 was greater than the tabulated paired ‘t’
value of 2.15, which showed that there was statistically significant
difference at 0.05 level of significance and 14 degrees of freedom between
pre and post results. The pre test mean was 10.86, post test mean was 6.1
and mean difference was 4.76, which showed improvements regarding
sensation and functional status in response to transcutaneous electrical nerve
stimulation for 4 weeks.
In the analysis and interpretation of Lower Extremity Functional Scale in group A:
The paired‘t’ value of 26 was greater than the tabulated paired ‘t’
value of 2.15, which showed that there was statistically significant
difference at 0.05 level of significance and 14 degrees of freedom between
pre and post results. The pre test mean was 38.73, post test mean was 55.30
and mean difference was 16.57, which showed improvements regarding
sensation for 4 weeks.
The above study results support the result of present study in
which Transcutaneous Electrical nerve Stimulator has got improvement
in above mentioned parameters in group A patients with diabetic
peripheral neuropathy.
32
In the analysis and interpretation of Neuropathy Total Symptom
Score-6 (NTSS-6) in group B:
The paired‘t’ value of 30.98 was greater than the tabulated paired ‘t’
value of 2.15, which showed that there was statistically significant
difference at 0.05 level of significance and 14 degrees of freedom between
pre and post results. The pre test mean was 10.40, post test mean was 2.40
and mean difference was 8, which showed improvements regarding pain and
functional status in response to external electrical muscle stimulation for 4
weeks.
In the analysis and interpretation of Lower Extremity Functional Scale B:
The paired‘t’ value of 28.99 was greater than the tabulated paired ‘t’
value of 2.15 , which showed that there was statistically significant
difference at 0.05 level of significance and 14 degrees of freedom between
pre and post results. The pre test mean was 39.27, post test mean was 71.20
and mean difference was 31.93, which showed improvements regarding
Lower Extremity Functional Scale in response to external electrical
muscle stimulation for 4 weeks.
The study results of l. Reichstein et al .supports the result of
present study in which external electrical muscle stimulation has got
improvement in above mentioned parameters in group B patients with
diabetic peripheral neuropathy.
33
IN THE COMPARISON OF GROUP – A AND GROUP – B:
In the analysis and interpretation of Neuropathy Total Symptom Score-6 (NTSS-6) between group A and group B: In the analysis and interpretation of Neuropathy Total Symptom
Score-6 (NTSS-6), the unpaired ‘t’ value of 9.92 was greater than the
tabulated ‘t’ value of 2.05, at 0.05 level of significance and 28 degrees of
freedom, which showed that there was statistically significant difference
between pre test Vs post test results of group A and group B. The mean
value of group A was 4.76, mean value of group B was 8 and mean
difference was 3.24 which showed that there was significant improvements
regarding pain and functional status in group B compared to group A in
response to treatment.
In the analysis and interpretation of Lower Extremity Functional Scale between group A and group B: In the analysis and interpretation of Lower Extremity Functional
Scale, the unpaired ‘t’ value of 12.538 was greater than the tabulated ‘t’
value of 2.05, at 0.05 level of significance and 28 degrees of freedom, which
showed that there was statistically significant difference between pre test Vs
post test results of group A and group B. The mean value of group A was
16.57, mean value of group B was 31.93 and mean difference was 15.36
which showed that there was significant improvements regarding Lower
Extremity Functional Scale in group B compared to group A in response to
treatment.
34
Based on the statistical analysis and interpretation of the results, the
present study showed that there was significant improvement regarding pain,
functional status, Neuropathy Total Symptom Score-6 (NTSS-6) and
Lower Extremity Functional Scale values in patients with diabetic
peripheral neuropathy treated with external electrical muscle stimulation
than with Transcutaneous electrical nerve stimulation .
Therefore, the present study is accepting alternate hypothesis and
rejecting null hypothesis.
35
REASON FOR IMPROVEMENT FOR EXTERNAL ELECTRICAL MUSCLE STIMULATION.
External electrical muscle stimulation activates the dorsal column that inhibits the c fibers thus interrupting gating pain in put so there by pain is been reduced.
External electrical muscle stimulation suggest a improvement in the skin perfusion this due to electrical muscle stimulation act as a neural vasodilatation.
The high frequency and twin peak properties of the current produce neural vasodilatation on both place of electrode.
Activates large diameter sensory nerve there by inhibits sympathetic vasoconstriction neuron activity.
Activates small to medium sized sensory neurons to release vasodilatory neurotransmitter.
Electrical muscle stimulation to the lower limb increases the up take of carbohydrate in lower limb than voluntary cycling exercise.
Unlike during voluntary contraction the larger motor neuron innervating fast twitch fiber is the first one to be activated, owing to their larger neuron axon s with low in put resistance against electrical muscle stimulation.
External electrical muscle stimulation increases insulin sensitivity and GLUT-1 and GLUT-4 distribution is being improved.
Micro vascular blood supply and insulin resistance improved in diabetic peripheral neuropathy patients.
36
REASON FOR IMPROVEMENT FOR TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
TENS reduces the conduction velocity of the afferent fibers so there by reduces the pain sensation.
The peripheral conduction is slowed the volume of nociceptive traffic is reduced and this will reduce over all perception of pain.
TENS releases potent vasodilator, calcitonin which is gene related peptide. So there is observed increased in the peripheral blood flow.
REASON FOR IMPROVEMENT FOR EXTERNAL
ELECTRICAL MUSCLE STIMULATION THAN
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
External electrical muscle stimulation increases insulin sensitivity and GLUT-1 and GLUT-4 distribution is being improved.
Micro vascular blood supply and insulin resistance improved in diabetic peripheral neuropathy patients.
External electrical muscle stimulation activates the dorsal column that inhibits the c fibers thus interrupting gating pain in put so there by pain is been reduced.
37
SSUUMMMMAARRYY AANNDD CCOONNCCLLUUSSIIOONN
SSuummmmaarryy::
TThhee oobbjjeeccttiivvee ooff tthhee ssttuuddyy wwaass ttoo ccoommppaarree tthhee eeffffeecctt ooff external
electrical muscle stimulation versus Transcutaneous Electrical Muscle
Stimulator in management of diabetic peripheral neuropathy.
To conduct the study, a total number of 30 patients, were selected
by random sampling method after the consideration of inclusion and
exclusion criteria. The informed consents were obtained from subjects
individually.
NNTTSSSS--66 aanndd LLEEFFSS wweerree ttaakkeenn aass ppaarraammeetteerrss ttoo mmeeaassuurree tthhee
cchhaannggeess..TThhee pprree ttrreeaattmmeenntt ddaattaa wweerree ccoolllleecctteedd ffoorr ggrroouupp AA aanndd ggrroouupp BB
ssuubbjjeecctteess aanndd ccoommppuutteedd..
GGrroouupp AA wweerree ggiivveenn TTEENNSS aanndd GGrroouupp BB wwrreerr ggiivveenn external
electrical muscle stimulation treatment daily. The result of the same
parameter were recorded for comparison after three weeks of treatment.
The paired ‘t’ test was used to compare the pre versus post
treatment result of Group A and GGrroouupp BB sseeppeerraatteellyy..TThhee uunnppaaiirreedd ‘‘tt’’tteesstt
wwaass uusseedd ttoo ccoommppaarree tthhee mmeeaann ddiiffffeerreennccee ooff Group A and GGrroouupp BB..
In the analysis and interpretation of Neuropathy Total
Symptom Score-6 (NTSS-6), the unpaired ‘t’ value of 9.92 was greater
than the tabulated ‘t’ value of 2.05, at 0.05 level of significance and 28
degrees of freedom, which showed that there was statistically significant
difference between pre test Vs post test results of group A and group B.
The mean value of group A was 4.76, mean value of group B was 8 and
mean difference was 3.24 which showed that there was significant
38
improvements regarding pain and functional status in group B compared
to group A in response to treatment.
In the analysis and interpretation of Lower Extremity
Functional Scale, the unpaired ‘t’ value of 12.538 was greater than the
tabulated ‘t’ value of 2.05, at 0.05 level of significance and 28 degrees of
freedom, which showed that there was statistically significant difference
between pre test Vs post test results of group A and group B. The mean
value of group A was 16.57, mean value of group B was 31.93 and mean
difference was 15.36 which showed that there was significant
improvements regarding Lower Extremity Functional Scale in group B
compared to group A in response to treatment.
Conclusion:
This study shows that there was reduction in cold, warm ,cold
pain threshold ,heat pain threshold, vibration perception threshold and
touch perception threshold diabetic peripheral neuropathy after treatment
with external electrical muscle stimulation.
Thus the study concluded that external electrical muscle
stimulation is effective treatment for diabetic peripheral neuropathy and
Neuropathy Total Symptom Score-6 (NTSS-6) and Lower Extremity
Functional Scale could be used as the assessment tools for cold, warm
,cold pain threshold ,heat pain threshold, vibration perception threshold
and touch perception threshold
39
RREECCOOMMMMEENNDDAATTIIOONNSS
A similar study can be conducted for reducing the blood sugar level in
type II Diabetic patients.
The Lower Extremity Functional Scale (LEFS) Neuropathy Total
Symptom Score-6 (NTSS-6) and Neuropathy Disability Score (NDS)
parameters can be used for other poly neuropathy conditions.
The effectiveness of transcutaneous electrical nerve stimulation in
reducing the pain in diabetic peripheral neuropathy.
The effectiveness of Transcutaneous electrical nerve stimulation and
external electrical muscle stimulation in stroke, peripheral nerve lesion
and neuropathy conditions.
40
BBIIBBLLIIOOGGRRAAPPHHYY
John Low, ann Reed, electro therapy explained principles and
pratice”, Butterworth Heinemann company, 2nd Ed., 1990.
Mahajan.B.K. “Methods in Biostatics for Medical Students and
Research Workers”, 5th Ed.,1989.
Joslin’s Diabetes Mellitus by perter H Dennatt and William
C.Knowler.
Diabetes Mellitus Management by wellberg.Henriksson H,Rinco
J,Lierath J.R.
TENS clinical applications and related theory by Deirdre M.Walsh.
Physical modalities by paul.d.hooper.
Electrotherapy evidence based practice by Sheila kitchen 11th edition.
Clinical electrotherapy by roger.m.nelson/ dean p.
Clayton’s electrotherapy theory and practice by forster and
palastanga.
Principles and practice of electrotherapy by joseph kahn.
Physical agents, theory and practice for the physicaltherapist assistant
by Barbara j. Behrens susan l.michlouitz
41
RREEFFEERREENNCCEESS
Hultman E and Spriet LL. Skeletal muscle metabolism,
contraction force and glycogen utilization during prolonged electrical
stimulation in humans. J Physiol 374: 493-501, 1986.
Reichstein L, Labrenz S, Ziegler D, Martin S. Effective treatment of
symptomatic diabetic polyneuropathy by High-Frequency External
Muscle Stimulation. Diabetologia 2005; 48: 824–828.
Per M. Humpert, MD, Medizinische Klinik 1 und Klinische Chemie, Im
Neuenheimer Feld electrical muscle simulation improves burning
sensations and sleeping disturbance in patient with diabetic
symptomatic neuropathy 410, 69120 Heidelberg, Germany.
Peters Ej,Armstrong DG, Wunderlich RP,Bosma J,Stacpoole-Shea
S,Lavery LA.the benefit of electrical simulation to enhance perfusion in
patient with diabetic Department of Orthopaedics, University of Texas
Health Science Center, San Antonio, TX 78250, USA.
Md Edward j.Bastyr,phD Karen L.Price,MDVera Bril and the MBBQ
Study Group. Development and validate a neuropathy sensory symptom
scale, the Neuropathy Total Symptom Score-6 (NTSS-6), which
evaluates individual neuropathy sensory symptoms in patients with
diabetes mellitus (DM) and Diabetic peripheral neuropathy (DPN).
42
M.Lankisch, S.Labrenz, j.Haensler, L.Heinemann,S. Martin.New
Possibilities for The Treatment of Type 2 Diabetes Mellitus by Means
of External Electrical Muscle Stimulation.
Jill M Binkley to assess the reliability constructs validity, and
sensitivity to change of the Lower Extremity Functional Scale.
Chilibeck PD, Bell G, Jeon J et al (1999) Functional electrical
stimulation exercise increases GLUT-1 and GLUT-4 in paralyzed
skeletal muscle. Metabolism 48:1409–1413.
Hamada T, Hayashi T, Kimura T, Nakao K, Moritani T (2004)
Electrical stimulation of human lower extremities enhances
Energy consumption, carbohydrate oxidation, and whole body glucose
uptake. J Appl Physiol 96:911–916.
Lundeberg T, Kjartansson J, Samuelsson U (1988) Effect of
electrical nerve stimulation on healing of ischaemic skin flaps,
Lancet 2:712–714.
S. O. Oyibo, K. Breislin, A. J. M. Boulton .Electrical stimulation
therapy through stocking electrodes for painful diabetic neuropathy: a
double blind, controlled crossover study. Article first published
online: 4 JUN 2004.
43
APPENDIX
DEFINITION OF TERMS
Diabetic peripheral neuropathy
The term Diabetic peripheral neuropathy encompasses a wide range of
disorders in which the nerves outside of the brain and spinal cord—
peripheral nerves—have been damaged. Peripheral neuropathy may also
be referred to as peripheral neuritis, or if many nerves are involved, the
terms polyneuropathy or polyneuritis may be used.
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS) is the use of
electric current produced by a device to stimulate the nerves for
therapeutic purposes. TENS by definition covers the complete range of
transcutaneously applied currents used for nerve excitation although the
term is often used with a more restrictive intent, namely to describe the
kind of pulses produced by portable stimulators used to treat pain.
External electrical muscle stimulation
Electrical muscle stimulation (EMS), also known as neuromuscular
electrical stimulation (NMES) or electromyo stimulation is the elicitation
of muscle contraction using electric impulses. The impulses are generated
by a device and delivered through electrodes on the skin in direct
proximity to the muscles to be stimulated. The impulses mimic the action
potential coming from the central nervous system, causing the muscles to
contract. The electrodes are generally pads that adhere to the skin.
44
Neuropathy Total Symptom Score-6(NTSS-6).
The NTSS-6 questionnaire was developed to evaluate the
frequency and intensity of individual neuropathy sensory symptoms
identified frequently by patients with DPN (ie, numbness and/or
insensitivity; prickling and/or tingling sensation; burning sensation;
aching pain and/or tightness; sharp, shooting, lancinating pain; and
allodynia and/or hyperalgesia).
Lower Extremity Functional Scale (LEFS).
The Lower Extremity Functional Scale (LEFS) can be used to
evaluate the functional impairment of a patient with a disorder of one or
both lower extremities. It can be used to monitor the patient over time
and to evaluate the effectiveness of an intervention
45
PPAARRAAMMEETTEERR
Neuropathy Total Symptom Score-6 (NTSS-6)
Subjective Peripheral Neuropathy Screen Questionnaire
Full Name: _________________________________________
Date: __________
Please take a few minutes to answer the following questions about the
feeling in your legs and feet. Check yes or no based on how you usually feel,
Thank you.
Do you ever have legs and/or feet that feel numb? �Yes �No.
Do you ever have any burning pain in your legs and/or feet?
�Yes �No.
Are your feet too sensitive to touch? �Yes �No
Do you get muscle cramps in your legs and/or feet? �Yes �No
Do you ever have any prickling or tingling feelings in your legs or
feet? �Yes �No
Does it hurt at night or when the covers touch your skin? �Yes �No
When you get into the tub or shower, are you unable to tell the hot
water from the cold water with your feet? �Yes �No
Do you ever have any sharp, stabbing, shooting pain in your feet or legs? �Yes �No
Have you experienced an asleep feeling or loss of sensation in your
legs or feet? �Yes �No
46
Do you feel weak when you walk? �Yes �No
Are your symptoms worse at night? �Yes �No
Do your legs and/or feet hurt when you walk? �Yes �No
Are you unable to sense your feet when you walk? �Yes �No
Is the skin on your feet so dry that it cracks open? �Yes �No
Have you ever had electric shock-like pain in your feet or legs? �Yes
�No .
The Lower Extremity Functional Scale (LEFS)
Overview: The Lower Extremity Functional Scale (LEFS) can be used to
evaluate the functional impairment of a patient with a disorder of one or both
lower extremities. It can be used to monitor the patient over time and to
evaluate the effectiveness of an intervention. The authors are from
McMaster University in Hamilton Ontario.
Patient instructions: Today does you or would you have any difficulty at all
with these activities?
Activities (20):
Any of your usual work housework or school activities
Your usual hobbies recreational or sporting activities.
Getting into or out of the bath
Walking between rooms
Putting on your shoes or socks
Squatting
Lifting an object like a bag of groceries from the floor
Performing light activities around your home
Performing heavy activities around your home
47
getting into or out of a car
walking 2 blocks (about 1/6th mile or about 250 meters)
walking 1 mile (1.6 km)
going up or down 10 steps (about 1 flight of stairs)
standing for 1 hour
sitting for 1 hour
running on even ground
running on uneven ground
making sharp turns while running fast
hopping
rolling over in bed
Response Points unable to perform
activity or extreme
difficulty
0
quite a bit of
difficulty
1
moderate difficulty 2
a little bit of
difficulty
3
no difficulty 4
48
The Lower Extremity Functional Scale score = sum (points for all 20
activities)
Interpretation:
minimum score: 0
maximum score: 80
The lower the score the greater the disability.
The Minimal Detectable Change (MDC) is 9 scale points.
• The Minimal clinically Important Difference (MCID) is 9 scale points.
Percent of maximal function =
= (LEFS score) / 80 * 100
TECHNIQUE:
Type 2 DM patients, who were only treated with a diet and/or oral
Anti diabetics were included in this 12 week study. After an Introductory
phase of 2 weeks with the use of an EMS unit, the treatment was given at the
patient’s disposal. On average, the test Persons used the unit daily during the
following 4months.
Alternately the electrodes were placed in the area of the Musculature
of thighs and the shank. The treatment was given for twenty min for each
patient. Each period of application and intensity was recorded by the units.
After this 4months period of treatment the units were given back. The
course of the above mentioned parameters. A square-wave biphasic pulses of
0.2-ms duration at a frequency of 20 Hz with a duty cycle of 1-s
stimulation/1-s pause, because our laboratory has previously reported that
parameters used can induce the highest o2 with this procedure. Both muscle
49
groups (lower legs and tight) were sequentially stimulated to co contract in
an isometric manner elicited from an electrical stimulator.
Fig- 1: Treatment given with stimulator.
Fig 2: Treatment given with TENS.
50
INFORMED CONSENT TO PARTICIPATE VOLUNTARILY IN A
RESEACH INVESTICATION
NAME :
AGE :
SEX :
OCCUPATION :
ADDRESS FOR COMMUNICATION :
DECLARATION
I have fully understood the nature and purpose of the study. I accept to
be a subject in this study. I declare that the above information is true to my
knowledge.
DATE :
PLACE :
Signature of the subject
51
ASSESSMENT CHART
NAME :
AGE :
SEX :
SIDE :
MODE OF TREATMENT : External Electrical Muscle Stimulation versus TENS
MEASUREMENT : PARAMETER BEFORE
TREATMENT AFTER TREATMENT
NTSS – 6 LEFS